Smart oscillating positive expiratory pressure device

ABSTRACT

An oscillating positive expiratory pressure system including an oscillating positive expiratory pressure device, an adapter coupled to the device, and a control module coupled to the adapter. The control module provides real time information about the use of the device, and provides feedback and storage of the information to improve the use thereof.

This application claims the benefit of U.S. Provisional Application62/699,338, filed Jul. 17, 2018 and entitled “Smart Oscillating PositiveExpiratory Pressure Device,” and of U.S. Provisional Application62/613,685, filed Jan. 4, 2018, and also entitled “Smart OscillatingPositive Expiratory Pressure Device,” the entire disclosures of whichare hereby incorporated herein by reference.

TECHNICAL FIELD

The embodiments disclosed herein relate generally to a smart oscillatingpositive expiratory pressure device, and to methods for the use andassembly thereof.

BACKGROUND

Chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF)may cause an increase in the work of breathing that leads to dyspnea,respiratory muscle fatigue and general discomfort. Oscillating positiveexpiratory pressure (OPEP) treatments may be used as a drug-free way toclear excess mucus from the lungs of COPD and CF patients. OPEP may alsobe used post-operatively to reduce the risk of post-operative pulmonarycomplications. Typically, OPEP devices provide minimal feedback to theuser or caregiver about the performance and/or effectiveness of thedevice during a treatment session. In addition, a large percentage (60%)of COPD patients do not adhere to prescribed therapy, with hospitalsystems carrying the burden of non-compliant patients that return to thehospital within 30 days. In addition, OPEP devices typically do notprovide feedback regarding therapy adherence, progress tracking orproper usage technique.

SUMMARY

Briefly stated, in one embodiment, a smart OPEP device provides feedbackto the user (patient or caregiver) regarding the frequency, meanpressure and amplitude of the pressure oscillations generated during atreatment session. In addition, data and information gathered regardingthe performance of the OPEP device may be archived and analyzed toprovide an overview of the user's progress, which may be made availableto health care providers and insurers, for example, to monitor treatmentadherence. Patient specific data may be provided to monitor trends overtime. Performance targets and/or limits may be set to assist the user inachieving correct techniques, and treatment effectiveness may beevaluated by surveying the patient's quality of life and linking it toperformance. In addition, with performance characteristics beingmeasured, the user may set up the device, and the user may be motivatedby various feedback including counting breaths or by playing games basedon the measurements.

In one embodiment, a smart accessory for an oscillating expiratorypressure device includes an adapter having a first end, which may becoupled to the oscillating positive expiratory pressure device, a secondend opposite the first end, which may be coupled to a mouthpiece, a flowchannel defined between the first and second ends, and a portcommunicating with the flow channel between the first and second ends. Aflexible membrane is disposed across the port and includes a first sidein flow communication with the flow channel and an opposite second sidedefining in part a chamber. A pressure sensor and/or microthermal flowsensor is in flow communication with the chamber. A control module iscoupled to the adapter and is operative to collect data from thepressure sensor and/or microthermal flow sensor.

In one aspect, the adapter may be decoupled from the oscillatingpositive expiratory pressure device, and the control module may bedisconnected from the adapter, and set to the side. A connection ismaintained between the flexible membrane and the adapter, for examplewith a tether. In one embodiment, the flexible membrane is moveable froma first position wherein the membrane is disposed across the port anddefines in part a chamber and a second position wherein the membrane isnot disposed across the port. The adapter, with the membrane attached,may be washed, with the membrane then moved to the first position andthe control module reconnected to the adapter.

The present embodiments, together with further objects and advantages,will be best understood by reference to the following detaileddescription taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph of an OPEP pressure waveform that identifies variousperformance characteristics.

FIG. 2 is a block diagram of an OPEP device with smart capabilities.

FIG. 3 is a perspective view of a pressure sensor.

FIG. 4 is a partial, exploded perspective view of one embodiment of asmart OPEP.

FIGS. 5A-G show various flow sensors.

FIG. 6 is a perspective view of a flex sensor.

FIGS. 7A and B are partial cross-sectional views of an OPEP device witha flex sensor in an un-flexed and flexed configuration respectively.

FIGS. 8A and B are partial cross-sectional views of an OPEP device witha non-contact position sensor in first and second pressureconfigurations respectively.

FIG. 9 is a partial cross-sectional view of an OPEP device with a springassisted non-contact position sensor.

FIG. 10 is a perspective view of a linear variable differentialtransformer (LVDT).

FIG. 11 is a partial cross-sectional view of an OPEP device with aconductive membrane.

FIG. 12 is a partial cross-sectional view of an OPEP device with a HallEffect sensor.

FIG. 13 is a partial cross-sectional view of an OPEP device with a lightcurtain sensor.

FIG. 14 is a partial cross-sectional view of an OPEP device with apotentiometer vane.

FIG. 15 is a partial cross-sectional view of an OPEP device with a piezoflex sensor.

FIG. 16 is a partial cross-sectional view of an OPEP device with aproximity sensor with a vane in a closed position.

FIG. 17 is a series of exploded perspective views of an OPEP device witha proximity sensor.

FIG. 18 is a perspective view of a PCB microphone.

FIG. 19 is a partial cross-sectional view of an OPEP device with aLED/Photo sensor.

FIG. 20 is a partial cross-sectional view of an OPEP device with anotherembodiment of a LED/Photo sensor.

FIG. 21 is a view of a user interface with an input screen.

FIG. 22 shows various LED outputs.

FIG. 23 is a view of a user interface with an output screen.

FIG. 24 is a partial view of a layout for a smart OPEP device.

FIG. 25 is a flow chart for performance targets for an OPEP device.

FIG. 26 is an exemplary graph of a sound signal.

FIG. 27 shows partial exploded and non-exploded views of an OPEP devicewith an LED output.

FIG. 28 is a view of an LED output.

FIG. 29 is perspective view of an OPEP device with an auditory orvibratory/tactile output.

FIG. 30 is a schematic of a system with an OPEP device communicatingwith a user interface via a wireless protocol.

FIG. 31 is a flow chart for a smart OPEP algorithm.

FIG. 32 shows examples of output screens for a user interface.

FIG. 33 is a view of a user interface with one embodiment of an outputgame.

FIG. 34 is a view of a user interface with one embodiment of an outputgame providing feedback on pressure and frequency.

FIG. 35 is a flow chart for performance limits.

FIG. 36 is a partial, perspective view of an OPEP device with dual flowsensors.

FIG. 37 is a flow chart for analyzing an I:E ratio.

FIG. 38 is a graph showing an I:E ratio.

FIG. 39 is a graph showing the linear regression of mean pressure v. QoLscore.

FIG. 40 is a flow chart for determining a relationship between a QoLscore and measurements taken from the OPEP device.

FIG. 41 is a flow chart and partial cross-sectional view of an activeOPEP device.

FIG. 42 is a graph of a flow-volume loop.

FIGS. 43A and B are partial cross-sectional views of control module inan installed and uninstalled position.

FIG. 44 is a block diagram of a smart OPEP system.

FIG. 45 is a flow chart of a treatment sequence using a smart OPEPsystem.

FIGS. 46A and B are exemplary graphs of pressure v. time data gatheredfrom a smart OPEP device.

FIGS. 47 and 48 are cross-sectional views of an OPEP device shown withand without internal components respectively.

FIG. 49 is a schematic illustrating the computer structure.

FIG. 50 is a schematic illustration of a communication system.

FIG. 51 is a perspective view of another embodiment of a smart OPEP.

FIGS. 52A and B are cross-sectional views of an adapter for the smartOPEP shown in FIG. 51.

FIG. 53 is a perspective view of the adapter and user interface/controlmodule.

FIG. 54 is a bottom view of the adapter and user interface/controlmodule shown in FIG. 53.

FIG. 55 is a perspective view of another embodiment of a smart OPEP.

FIG. 56 is a side view of the smart OPEP shown in FIG. 55.

FIG. 57 is a side view of the adapter and another embodiment of the userinterface/control module.

FIG. 58 is a bottom perspective view of the adapter and userinterface/control module shown in FIG. 57.

FIG. 59 is a perspective view of another embodiment of a smart OPEPincorporating the adapter and user interface/control module shown inFIG. 57.

FIG. 60 is a cross-sectional view of one embodiment of a pressuresensor.

FIG. 61 is a cross-sectional view of one embodiment of a flow sensor.

FIG. 62 is a block diagram illustrating a smart OPEP with a userinterface/control module.

FIGS. 63 and 63A-C is a flow chart illustrating the operation of oneembodiment of a smart OPEP.

FIG. 64 is a flow chart illustrating the operation of another embodimentof a smart OPEP.

FIG. 65 is a flow chart illustrating the operation of one embodiment ofa smart OPEP.

FIGS. 66A and B are front and rear perspective views of anotherembodiment of a smart OPEP.

FIG. 67 is a flow chart demonstrating the operation of the smart OPEPshown in FIGS. 66A and B.

FIG. 68 is a cross-sectional view of the smart OPEP shown in FIGS. 65Aand B.

FIG. 69 is an enlarged, partial cross-sectional view of smart OPEPadapter.

FIG. 70 is a perspective view of a T-connector with a membrane connectedthereto.

FIG. 71 is a bottom view of an electronic housing.

FIG. 72 is a perspective view of washable components of the smart OPEP.

FIG. 73 is a perspective view of the non-washable electronic housingcomponent of the smart OPEP.

FIGS. 74A and B are front and rear perspective view of the smartadapter.

FIG. 75 is a perspective view of one embodiment of a membrane.

FIG. 76A is a cross-sectional view of the membrane shown in FIG. 75.

FIG. 76B is a top view of the T-connector.

FIG. 77 is a partial cross-sectional view of the smart adapter and OPEP.

FIG. 78 is a graph of pressure curves from different embodiments of aT-connector (with and without a damping orifice).

FIGS. 79 and 80 are front and rear perspective views of anotherembodiment of a smart OPEP.

FIG. 81 is a top view of the smart OPEP shown in FIGS. 79 and 80.

FIG. 82 is a cross-sectional view of the smart OPEP taken along line82-82 of FIG. 81.

FIG. 83 is a top view of a PCB board incorporated into the smart OPEPshown in FIGS. 79 and 80.

FIG. 84 is a block diagram of one embodiment of smart OPEP systemincorporated into the embodiment of FIGS. 79 and 80.

FIGS. 85, 85A and 85B is a flow chart demonstrating the operation of thesmart OPEP shown in FIGS. 79 and 80.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

It should be understood that the term “plurality,” as used herein, meanstwo or more. The term “coupled” means connected to or engaged with,whether directly or indirectly, for example with an intervening member,and does not require the engagement to be fixed or permanent, althoughit may be fixed or permanent. It should be understood that the use ofnumerical terms “first,” “second,” “third,” etc., as used herein doesnot refer to any particular sequence or order of components. It shouldbe understood that the term “user” and “patient” as used herein refersto any user, including pediatric, adolescent or adult humans, and/oranimals.

The term “smart” refers to features that follow the general format ofhaving an input, where information is entered into the system, analysis,where the system acts on or modifies the information, and an output,wherein new information leaves the system. The phrase “performancecharacteristics” refers to measurements, such as frequency or amplitude,which quantify how well a device is functioning. Frequency is defined asthe number of oscillations in one second, however, during a typical OPEPmaneuver the rate of oscillations may not be consistent. Accordingly,frequency may be defined as the inverse of the time between oscillations(1/T), measured in Hz. This second definition calculates the frequencyof each oscillation and is averaged over a period of time. Max pressureis the maximum pressure for each oscillation, typically measured incmH₂O. Min pressure is the minimum pressure for each oscillation,typically measured in cmH₂O. Upper pressure is the average of the maxpressures for a given time period, for example one second. Lowerpressure is the average of min pressures for a given time period, forexample one second. Amplitude is the difference between the upper andlower pressures. Mean pressure is the average of the upper and lowerpressures. True mean pressure is the average of the entire pressurewaveform for a given time period. The true mean pressure is typicallylower than the means pressure because the typical pressure wavegenerated is not uniform, i.e., is skewed towards the min pressure.

Referring to FIG. 1, an OPEP pressure waveform is shown with variousperformance characteristics. FIG. 2 illustrates in block diagram form anOPEP device, illustrated as the dashed box that encloses the internalcomponents, configured with smart capabilities. One exemplary OPEPdevice 2 is the Aerobika® OPEP device, shown in FIGS. 4, 24, 27-30, 47and 48, available from Monaghan Medical Corporation, Plattsburg, N.Y.Various OPEP devices and structures are further disclosed in U.S. Pat.No. 8,985,111, issued Mar. 24, 2015 and entitled Oscillating PositiveExpiratory Pressure Device, U.S. Pat. No. 8,539,951, issued Sep. 24,2013 and entitled Oscillating Positive Expiratory Pressure Device, U.S.Pat. No. 9,220,855, issued Dec. 29, 2015 and entitled OscillatingPositive Expiratory Pressure Device, U.S. Pub. 2012/0304988, PublishedDec. 6, 2012 and entitled Oscillating Positive Expiratory PressureDevice U.S. Pub. 2015/0297848, Published Oct. 22, 2015 and entitledOscillating Positive Expiratory Pressure Device, and U.S. Pub.2015/0053209, Published Feb. 26, 2015 and entitled Oscillating PositiveExpiratory Pressure Device, the entire disclosures of which are herebyincorporated herein by reference. It should be understood that otherOPEP devices may be configured with other components that createpressure oscillations.

Referring to FIGS. 47 and 48, a user, such as a patient, interacts withthe OPEP device 2 via a mouthpiece 4. The OPEP device includes a housing6 enclosing a mouthpiece chamber 48, a chamber 14 a, 14 b, a chamberinlet 16 in communication with the mouthpiece, and one or more chamberoutlets 18. Typically, OPEP devices permit the user to inhale andexhale, although some devices may permit exhalation only. The housing 6has a front section 8, a rear section 10, and an inner casing 12, whichmay be separable so that the components contained therein can beperiodically accessed, cleaned, or reconfigured, as required to maintainthe ideal operating conditions.

The OPEP device 2 also includes an inhalation port 20, a one-way valve22, an adjustment mechanism 24, a restrictor member 26, a vane 28, and avariable nozzle 30, or vale assembly. As seen in FIGS. 47 and 48, theinner casing 12 is configured to fit within the housing 6 between thefront section 8 and the rear section 10, and partially defines thechamber 14 a, b, including a first chamber and a second chamber. Firstand second chamber outlets 18 are formed within the inner casing. TheOPEP device 2 may include an adjustment mechanism 24, with actuator 25,adapted to change the relative position of a chamber inlet 16. A user isable to conveniently adjust both the frequency and the amplitude of theOPEP therapy administered by the OPEP device 2 without opening thehousing and disassembling the components of the OPEP device. Forexample, the OPEP device may have a plurality of settings, for examplefive (5), including a high, medium and low.

The OPEP device 2 may be adapted for use with other or additionalinterfaces, such as an aerosol delivery device. In this regard, the OPEPdevice 2 is equipped with an inhalation port 20 in fluid communicationwith the mouthpiece 4. As noted above, the inhalation port may include aseparate one-way valve 22 configured to permit a user of the OPEP device2 both to inhale the surrounding air through the one-way valve 22 and toexhale through the chamber inlet 16, without withdrawing the mouthpiece4 of the OPEP device 2 from the user between periods of inhalation andexhalation. In addition, the aforementioned commercially availableaerosol delivery devices may be connected to the inhalation port 20 forthe simultaneous administration of aerosol therapy (upon inhalation) andOPEP therapy (upon exhalation).

The exhalation flow path 40 begins at the mouthpiece 4 and is directedthrough the mouthpiece chamber 48 toward the chamber inlet 16, which inoperation may or may not be blocked by the restrictor member 26, orvalve assembly which may include a valve seat and butterfly valve. Afterpassing through the chamber inlet 16, the exhalation flow path 40 entersthe first chamber 14 a and makes a 180° turn toward the variable nozzle30. After passing through an orifice of the variable nozzle, theexhalation flow path enters the second chamber 14 b. In the secondchamber 14 b, the exhalation flow path 40 may exit the second chamber41, and ultimately the housing 6, through at least one of the chamberoutlets 18. It should be understood that the exhalation flow path 40identified by the dashed line is exemplary, and that air exhaled intothe OPEP device 2 may flow in any number of directions or paths as ittraverses from the mouthpiece 4 to the outlets 18.

Referring to FIGS. 53-56, a first embodiment of an adapter 400 and userinterface/control module 408 is shown. In general, the adapter 400includes a body 402, a conduit 404 extending from the body 402, and aplug 406 positioned along and inserted into the conduit 404. The userinterface/control module 408, which may include an instrument formeasuring pressure positioned at an outlet 403 of the conduit 404.

The body 402 may be sized and shaped for integration with existing OPEPdevices, for example, as shown in FIGS. 51, 55 and 59, with themouthpiece 4 of the OPEP device 2. For example, the body 402 may include2 mm ISO male/female conical connectors 410, 412 shaped and sized toconnect to a port 414 on the OPEP device 2 and an insert portion 416 ofthe mouthpiece 4 respectively. In operation, the mouthpiece 4 isdisengaged from the OPEP device 2, and the adapter is disposed, orcoupled, between the mouthpiece and the OPEP device. It should beunderstood that the adapter may be coupled to other components of theOPEP, such as the inhalation port 20.

Extending from the body 402 is a conduit 404 configured to transmit apressure from within the OPEP device 2 to the user interface/controlmodule 408. An inlet 405 permits a pressure within the body 402 to betransmitted into the conduit 404. As shown, the conduit 404 extends awayfrom the body 402, then angles alongside the OPEP device 2, therebymaintaining the portability and ergonomics of the OPEP device 2, andavoiding the need for lengthy tubing or additional attachments.

The user interface/control module 408 is positioned at an outlet 403 ofthe conduit 404. It should be appreciated, however, that a portion ofthe conduit 404 could extend into a passageway in the userinterface/control module 408, or other instrument for measuringpressure. Preferably, the user interface/control module 408 may includeone or more of a numerical, color, shape, or other visual indicia, orone or more of a sound or other auditory indicia, or a combination ofone or more of each of a visual indicia and an auditory indicia. In oneof the exemplary embodiments shown, the user interface/control module408 includes a visual display, such as an array of LED lights 150 and adisplay screen 420, which may display various data, as further explainedbelow. Preferably, the user interface/control module 408 is positionedrelative to the respiratory treatment device such that the indicator andindicia are visible to the user during treatment. As shown in theexemplary embodiment in FIGS. 51 and 55, the user interface/controlmodule 408 is positioned relative to the respiratory treatment device inthe form of an OPEP device 2 such that the visual display 418, 420 arepositioned adjacent a top of the device and are viewable to a user ofthe OPEP device 2 during treatment. Referring to FIG. 59, the userinterface/control module 408 is positioned along the side of the OPEPdevice 2, but with the visual display 418 facing the user.

The plug 406 is insertable by press-fit in and/or along the conduit 404at a point where the conduit 404 angles alongside the OPEP device 2. Inone embodiment, the plug may not be removed, but may be made of aself-sealing material, such as a silicone material, allowing a needle orother similar instrument to be inserted and removed for cleaningpurposes while maintaining a seal. In another embodiment, the plug maybe periodically removed for cleaning of the adapter 400. As shown inFIG. 52B, the plug 406 includes a cutout 409 that may be aligned with apassage 410 in the conduit 404. When the plug 406 is inserted into theconduit 404 such that the cutout 409 is partially or completely alignedwith the passage 410, a pressure stabilizing orifice 407 is formed inthe conduit 404. The pressure stabilizing orifice 407 is configured todampen oscillations in the pressures transmitted from the OPEP device 2to the user interface/control module 408.

The size and shape of the pressure stabilizing orifice 407 may beselectively adjustable by rotating the plug 406 relative to the passage410, thereby increasing or decrease the amount of damping. While thepressure stabilizing orifice 407 is shown as being adjustable, it shouldbe appreciated that the size and shape of the pressure stabilizingorifice 407 may be fixed. Furthermore, it should be appreciated that thepressure stabilizing orifice 407 may be positioned anywhere along theconduit 404 between the body 402 and the user interface/control module408. However, in order for the pressure stabilizing orifice 407 toeffectively dampen oscillations in the pressures transmitted from theOPEP device 2 to the user interface/control module 408, thecross-sectional area of the pressure stabilizer orifice 407 should beless than a cross-sectional area of the conduit 404 along the entirelength of the conduit 404. In this embodiment, the pressure stabilizerorifice 407 has a diameter of 0.5 mm to 1.5 mm, or a cross-sectionalarea between 0.196 mm^(2 and) 1.767 mm². Preferably, the pressurestabilizer orifice 507 has a diameter of 0.6 mm to 0.9 mm, or across-sectional area between 0.283 mm^(2 and) 0.636 mm^(2.)

Referring to FIGS. 66A and B, 68-74B and 79-83, another embodiment of anadapter 600, 900 and user interface/control module 608, 908 is shown. Ingeneral, the adapter 600, 900 includes a T-connector 620 configured witha cylindrical tube 622 defining a flow channel 624. The tube has firstand second ends 626, 628, each configured as tubular portions, and aport 630 communicating with the flow channel between the first andsecond ends. The first end 626 may have a smaller outer diameter thanthe second end, and is shaped and dimensioned to be received in atubular portion 632 of the OPEP, while the second end 628 is shaped anddimensioned to receive a tubular portion 634 of the mouthpiece 4. Theport has a cylindrical body 636 and a rim portion 638 with an upper face640. A circumferential groove 642 is formed in the face. The rim portionfurther defines a peripheral groove 644 extending around a circumferenceof the cylindrical body. A plurality of tabs 646 extend radiallyoutwardly from the rim portion, with the tabs have a bottom taperedleading edge 648, or ramp, to promote a sliding engagement with thecontrol module 608. A through opening 650 extends through the rimportion adjacent one side of the adapter, as shown in FIG. 76B.

A flexible membrane 660 includes an annular rim 662 having an upper flatface 664, and a downwardly extending ridge 668. The ridge is shaped anddimensioned to be received in the circumferential groove 642 of theport, so as to form a hermetically sealed (airtight) engagementtherewith. The membrane 660 further includes an annular hingeportion/bellows 670, or thin J-shaped wall connected to a centralcylindrical body portion 672. The membrane is preferably made ofsilicone rubber, for example Silopren silicone rubber available fromMometive. The body 672 has a thickness, e.g., 2.5 mm, such that the bodyhas a sufficient mass relative to the bellows portion, having athickness of 0.30 mm, which provides better feedback to a controlmodule. A tether 678 extends downwardly from the rim at a spacedlocation from the wall. The tether has a tapered nose portion 680 and anannular catch 682 defining a shoulder. The tapered nose portionfacilitates insertion through the opening 650, with the tether beingpulled through the opening 650 until the shoulder of the catch engagesan underside of the rim. The membrane 660 is moveable from a first,engaged position where the ridge 668 is inserted into the groove 642,and a second, disengaged position, where the ridge is removed from thegroove, for example to allow the underside of the membrane and interiorof the T-connector to be washed or cleaned. The tether 678 maintains aconnection between the membrane and T-connector when the membrane ismoved between the first and second positions. The bottom side 674 of themembrane is in fluid communication with the flow channel 624 of theT-connector, while an opposite top side 676 defines in part a chamber684.

Referring to FIGS. 66A and B, 68-74B and 79-84, the control module 608,908 includes a housing 700, 910 having upper and lower casings 702, 704,912, 914. The lower casing 702, 912 includes a chamber portion 706overlying the top side 676 of the membrane, with the top side andchamber portion defining the chamber 684. The chamber portion 706 has agenerally circular, or cylindrical shape, and includes a top wall 708and a first circumferential wall 710 extending downwardly from the topwall, with the top wall and first circumferential wall defining in partthe chamber. A second circumferential wall 712 is disposed radiallyoutwardly from the first wall and is connected thereto with a webportion 714 having a plurality of openings. A plurality of correspondingtabs 716 (shown in FIG. 71) extend radially inwardly from a bottom edgeof the second wall, with spaces 718 defined between the tabs. Inoperation, the housing 700 is disposed over the port 630 and membrane660, with the tabs 638 on the port being aligned with the spaces 718.The housing 700, 910 is pressed against the membrane 660 and rotatedsuch that the tabs 716 are biased by the tabs 638 on the port (shown as5 on each), pressing the bottom of the web 714 against the top surfaceof the membrane rim 662 as the rib/ridge 668 is pressed into the groove642 thereby forming the hermetic seal and defining the interior chamber684 between the membrane and chamber portion of the housing. The controlmodule 608, 908 may be disconnected in a reverse manner by rotating thecontrol module relative to the port until the tabs 638 are aligned withthe spaces 718, whereinafter the two components may be moved axiallyaway from each other. After separation, the membrane 660 may also bemoved away from the port to allow for washing/cleaning of the membraneand T-connector, while being maintained in connection the T-connectorvia the tether.

The chamber portion further includes an annular flange (FIG. 71), ortravel/stop member 720, that extends downwardly from the top wall and isdisposed over the membrane. The annular flange does not extend 360degrees, but rather has a mouth portion, or opening, positioned adjacenta sensor port 724, such that that air within the confines of the annularflange volume may escape to other portions of the chamber, for examplewhen the membrane engages the stop member. The stop member 720 is spacedapart from the top side 676 of the central body portion thereof. Thestop member limits the upper travel of the central body portion duringuse. The lower casing 704 extends longitudinally over the top of theOPEP device. Vent holes 722 may be formed in bottom wall thereof toprovide cooling for electronic components housed therein.

A port 724 is in fluid communication with the interior chamber. In oneembodiment, a pressure sensor 730 is coupled to the port, for example bypressing the sensor against a seal 728, e.g., O-ring, with an inputportion 726 of the sensor being in fluid communication with the interiorchamber. The upper casing 702, 914 is releasably coupled to the lowercasing 704, 912 in one embodiment, for example with fasteners 732, withthe upper casing pressing the sensor 730 against the seal. A circuitboard 740, 940 and battery 742, together with the pressure sensor 730,are housed in the lower and/or upper casing, which define an interiorspace in the housing. The user interface/control module 608 includes avisual display, such as an array (one or more) of LED lights 750, amicro USB port 422, an SD-card port 424 and a switch (on/off) 430. Inthe embodiment of FIGS. 79-83, the control module includes anaccelerometer 930, disposed on and integrated into the circuit board940. One suitable accelerometer is an MEMS Accelerometer Part No.MMA8452Q available from NXP Semiconductor, for example. Theaccelerometer may be used instead of the switch 430, or in combinationtherewith. Preferably, the user interface/control module 608 ispositioned relative to the respiratory treatment device such that theindicator and indicia are visible to the user or care giver duringtreatment.

Referring to another embodiment shown in FIG. 77, the T-connectorincludes a curved wall 780 extending below the port. The curved walldefines a second chamber 782 in combination with the lower side 674 ofthe membrane 660. A damping orifice 784 extends through the curved walland provides fluid communication between the flow channel 624 and thesecond chamber 782. In one embodiment, the damping orifice 784 has adiameter in the range of 0.5 to 1.5 mm. In this way, first and secondchambers 684, 782 are defined on opposite sides of the membrane, withthe first chamber being hermetically sealed, and with the second chamber782 being in fluid communication with the flow channel via the dampingorifice.

Referring to FIGS. 53-56, during administration of OPEP therapy, anoscillating back pressure is transmitted to the user of the OPEP device,which is received by the user at the mouthpiece. When the adapter anduser interface/control module 408 are connected to such an OPEP device,for example the OPEP device 2, the oscillating pressure is transmittedfrom within the body 402 to user interface/control module 408 throughthe conduit 404. The oscillations in the pressure are dampened, however,by the pressure stabilizing orifice 407, as the flow of air along theconduit 404 through the pressure stabilizing orifice 407 is restricted.After the pressure has been dampened by the pressure stabilizing orifice407, the pressure is received and measured by the user interface/controlmodule 408, which in turn provides the user with a visual indication ofthe pressure achieved during administration of OPEP therapy. This allowsthe user or caregiver to monitor the treatment regimen or therapy toensure that the appropriate pressures are achieved for the prescribedperiod of time. In some instances, a treatment regimen or therapyalternating between exhalation at a high pressure for a predeterminedperiod of time and exhalation at a low pressure for a predeterminedperiod of time may be desirable. A visual or auditory indication of thepressure achieved during treatment will allow the user or caregiver todetermine the level of compliance with the prescribed treatment regimenor therapy. Various components of the OPEP and adapter are disclosed inU.S. Publication No. US2015/0224269A1, published Aug. 13, 2015, theentire disclosure of which is hereby incorporated herein by reference.

The shaded area 50 in FIG. 2 represents the internal volume, defined forexample by the mouthpiece chamber 48, which becomes pressurized when thevalve mechanism closes. The shaded area outside of the OPEP deviceboundary represents the “smart” features that include three operations:input, analysis and output. The input may come from the high pressurezone 50 as shown in FIG. 2, such as the adapter, although it mayoriginate from another part of the device depending on the measurementbeing taken or registered.

Inputs

The term “input” refers to any information that enters the smart OPEPsystem, and may take the form of raw data from a sensor, a command tostart a process or personal data entered by the user. For example, theinput may be a signal from one or more input components, such as asensor. For example, as shown in FIGS. 3 and 4, a pressure sensor 52generates an electrical signal as a function of the pressure in thesystem, or chamber 48. The pressure sensor may be used to calculate anyof the performance characteristics referred to above, as well as toevaluate the user's technique. A sensor assembly 54 may include ahousing 202 for a pressure sensor 52 placed on a printed circuit board(PCB), along with a BTLE module 56, a processor (e.g., microprocessor)60, LED indicator 154, memory, wireless communication capabilities and abattery 58, or solar aided charge, and may communicate with an outputcomponent, for example a user's (patient, caregiver and/or otherauthorized user) computing device, such as a mobile device 62, includinga smart phone or tablet computer. The assembly may be configured as aremovable control module 608, 908, shown in FIGS. 66A-69 and 79-84. Asingle pressure sensor 52 may provide all of the measurementrequirements. The pressure sensor may be a differential, absolute orgauge type of sensor. The sensor assembly is coupled to the OPEP device,with a cover 64 disposed over the assembly. The input component is inconsidered to be in “communication” with the chamber 48 if it is able tosense or measure the pressure or flow therein, even if the inputcomponent is separated from the interior of the chamber, for example bya membrane or other substrate (see, e.g., FIGS. 60, 61 and 68). Theinput component is operative to sense a flow and/or pressure andgenerate an input signal correlated to the flow or pressure.

Referring to FIGS. 5A-G, various flow sensors are shown that generate anelectrical signal as a function of the airflow 70 in the system. A flowsensor may be used to calculate the frequency, as well as evaluate theuser's technique. The flow sensors may include incorporating a venturi780 into the shape of the mouthpiece chamber (FIG. 5A), incorporatingpitot tubes 72, which compare pressure generated by flow stagnation atthe entrance of the pitot tube to that of the surrounding fluid anddetermine the fluid velocity (FIG. 5B), or using soundtransmitters/receivers 74 to measure the time it takes sound to travelfrom transmitter 1 (74) to receiver 2 (80), and then from transmitter 2(80) to receiver 1 (74) (FIG. 5C) and calculating the flow based on thedifferent in time being proportional to the flow velocity.Alternatively, as shown in FIG. 5D, air flow causes displacement in amagnetic component 82, which in turn changes the inductance of a coil84. The inductance of the coil is related to displacement, which may becorrelated to flow rate. A biasing spring 86 (e.g., tension orcompression), may be provided to return the magnet to the “zero-flow”position when no flow is present. Referring to FIG. 5E, air flow cause avane 88 to move that changes the resistance of a potentiometer 90, whichis related to flow rate. Again, a biasing spring 92 (e.g., torsion) maybe include to return the vane to the “zero-flow” position when no flowis present. Referring to FIG. 5F, a vane 94, having for example aplurality of blades, rotates in response to a flow, with the speed ofthe rotation shaft 96 correlated to the proportional flow rate.Referring to FIG. 5G, flow 70 passes over a heater wire 98, which thenbegins to cool. More current is passed through the wire to maintain aconstant temperature, with the amount of measured current correlated tothe flow rate.

Referring to FIGS. 43A and B, 68 and 82, the control module 54, 608, 908is not in fluid communication with the internal volume, e.g., mouthpiecechamber 48 or flow channel 624, or the OPEP device, but rather isseparated by flexible membrane 200, 660, which moves in response tochanges in pressure within the device, for example the chamber 48 orflow channel 624. In this way, the control module 54, 608 is incommunication with the chamber 48 or flow channel 624 via pulsationsfrom the membrane 200, 660, but the control module 54, 608, 908 is notin fluid communication with the chamber 48 or flow channel 624.

In this way, the OPEP device, or housing, may be cleaned withoutdamaging the electronic components, and those components also are not influid communication with the user's inspiratory and/or expiratory breathor flow. When the control module is removed, or moved to an uninstalledposition, the flexible membrane 200 remains attached to the housing 6,and the membrane 660 remains attached to the T-connector 620, forexample with the tether, even if the membrane is moved to an uninstalledposition.

At rest, the pressure in the OPEP chamber 48, 14 a, 14 b, is atmosphericor ambient. The pressure (P) in the flow channel 624, and the first andsecond chambers 684, 782 are same. As pressure in the chamber or flowchannel increases, an upward/outward force is applied to the membrane200, 660, causing it to move towards the module 54. Since a measurementchamber 202, 684, formed between the membrane 200, 660 and the module,is sealed with the membrane, the volume of air in the measurementchamber 202, 684 is decreased with while the pressure in the chamber202, 684 is increased. The control module measures the pressure changeinside the sealed measurement chamber and determines the pressure insidethe OPEP chamber 48 (or 14 a, 14 b), or flow channel 624, using aconversion algorithm. During inhalation, the pressure in the chamber 48,14 a and/or 14 b and flow channel 624, becomes negative, which imparts adownward or inward force on the membrane 202, 660. As the flexiblemembrane is pulled away from the control module 54, 608, 908, thepressure inside the measurement chamber is decreased, or becomesnegative. Again, the control module 54, 608, 908 measures this pressurechamber and determines the corresponding, or actual, pressure in thechamber 48 or flow channel 625. As such, the module 54, 608, 908measures pressure without being in fluid communication with the chamber48, or flow channel 624, and the user's inspiratory/expiratory flow.

Referring to FIGS. 77 and 78, the damping orifice 784 pre-damps thepulsations of the membrane 660, which can smooth the pressure curve withless pulsations, thereby providing an easier analysis for the algorithmand a more precise output.

Referring to FIGS. 44, 83 and 84, the controller 158, BTLE module, LEDindicator, memory, pressure sensor are in electrical contact with thepower source, e.g., battery. The controller receives a signal from thepressure sensor and sends/receives data to/from the BTLE module, whichthen communicate with the mobile device 62, or other user interfaceand/or processor. The controller also sends a signal to the LEDindicator 154, 750 as required, and can save data to, and recall datafrom, the internal memory The data can be further communicated to andstored on a memory card 950, an SD card installed in the port, or becommunicated via the micro USB port. A real time clock 952 and back-upbattery 954 may also be incorporated into the PCB board 940.

Referring to FIGS. 6, 7A and B, a flex sensor 100 is shown as beingdisposed adjacent a high pressure cavity or zone defined by the chamber48. The resistance through the flex sensor is proportional to the amountof flex applied and may be used as an indirect measurement of pressure.The flex sensor may be positioned on the low pressure side of a siliconemembrane 102. The membrane 102 moves in response to a pressure increaseinside the cavity or system, causing the sensor 100, cantilevered overthe membrane or an actuation pad extending therefrom, to flex. Themembrane 102 may include an actuation pad 104 that engages the flexsensor 100. The resistance change from the flexing maybe correlated tothe pressure in the system. The electronic components, including thesensor, are separated from the flow path by the membrane 102, whichprevents contamination. Cleanliness of the flow path may be particularlyimportant to CF patients. At the same time, the electronic componentsmay be easily removed for cleaning and disinfecting.

Referring to FIGS. 8A and B, a non-contact position sensor 106 mayprovide either an absolute or relative position of an object, and likethe flex sensor, may be used to indirectly measures pressure changes.Some types of non-contact position sensors are capacitive displacementsensor, ultrasonic sensors, and proximity sensors. The sensors may beused to measure the displacement of a moveable surface that respond topressure changes. At ambient, or atmospheric pressure, a base component108 coupled to a silicone bellow 112 is positioned a distance “x” mmfrom a sensor 110. As the pressure increases, the base 108, attached forexample with rolling bellows, is moved toward the sensor 110, e.g., capactive displacement sensor, and the distance “x” decreases. Therefore,the distance between the base 108 and the sensor 110 is inverselyproportional to the pressure. If the pressure increases, the distancedecrease, and vice versa. The sensor may also measure negative pressure,for examples as the distance “x” increases.

If the pressure inside the device is too high, the silicone bellows maynot be stiff enough to resist bottoming out. As shown in FIG. 9, anassist spring 112, such as a mechanical compression spring, may bedisposed between the base 108 and sensor 110. In this way, the system isable to measure increased pressures. As with the embodiment of FIGS. 7Aand B, the electronic components of FIGS. 8A, B and 9 are separated andisolated from the flow path by the silicone membrane or bellows. Inaddition, the electronic components may be removable.

Referring to FIG. 10, a linear variable differential transformer (LVDT)112 is shown. The LVDT is a contact sensor, and directly measures thelinear displacement of the flexible membrane 102 or base 108 shown inthe prior embodiments. The displacement may be correlated to pressure.

Referring to FIG. 11, a conductive membrane 114 is provided. Themembrane is made using silicone with conductive properties. As thepressure inside of the system increases, the membrane deflects and theresistance or capacitance changes, which may be correlated to thepressure.

Referring to FIG. 12, a magnet 116 is configured with a spring. As thepressure inside the system changes, the distance between the magnet andHall Effect sensor 120 may be correlated to pressure. A return spring118 may be coupled to the magnet.

Referring to FIG. 13, a light curtain 122 may be used to determine thedisplacement of a membrane 124, which is displaced by pressure. As thepressure increases, a base or platform portion 126 of a membrane movesthrough the light curtain 122, with the movement correlated to pressure.

Referring to FIGS. 5E and 14, a potentiometer vane 88 is disposed in theflow path 70. The amount of rotation of the vane is proportional to theflow inside the chamber, and ultimately to pressure. A return spring 92is incorporated to reset the vane when zero flow is present.

Referring to FIG. 15, a Piezo flex sensor 128 is disposed in the flowpath. The flex sensor bends in response to the air flow of the chamber.As the sensor bends, the resistance changes. The change of resistancemay be correlated to flow rate, and pressure.

Referring to FIGS. 16 and 17, a proximity sensor 130 is used to detectthe presence of nearby objects without physical contact. In this case, aproximity sensor 130 is used to detect if the tip of a vane 134 ispresent. Every time the vane oscillates, the sensor would detect itsposition and the time between oscillations can be calculated. In theclosed position, the vane comes within 5 mm of the sensor at the highestresistance setting. A lower resistance setting will decrease thedistance between the vane and the sensor.

Another embodiment uses a proximity sensor 136 to monitor the controlnozzle 30. As the valve/vane mechanism 134 opens and closes to createthe pressure oscillations, the flow within the device also oscillates.When the flow is high the control nozzle 30 is in the open state, andwhen the flow is low the control nozzle is in the closed state. Theopen/closed motion of the control nozzle may be detected and convertedto frequency.

An accelerometer measures proper acceleration and can be used tocalculate frequency from the vibrations as the valve/vane mechanism 26,134 opens and closes. The accelerometer may be placed on the device inthe location that provides the greatest vibration.

A microphone 140, similar to the one shown in FIG. 18, may be mounted ona PCB and placed in the same location as the proximity sensor in FIGS.16 and/or 17. The microphone would pick up the sound of the airflowstarting and stopping, plus any mechanical contact that occurs with theoscillating mechanism.

An LED 142 and Photo sensor 144 may be used to calculate the frequencyof the oscillating mechanism. In this arrangement, the LED is located onone side of the butterfly valve 146 and the photo sensor is on theother. As the valve opens, light passes through the valve seat and ismeasured by the photo sensor. As the valve closes, or engages the seat148, light is blocked from reaching the photo sensor. The timing of thisdata can be used to calculate the frequency.

Another LED/Photo sensor arrangement is shown in FIG. 20. In thisarrangement, the LED is located at the far side of the vane chamber 14b, and the photo sensor is located on the side wall by one of theexhaust ports 18. As the vane 134 pivots to one side, it blocks lightfrom reaching the photo sensor. As the vane pivots to the other side,light from the LED is able to reach the photo sensor. The timing of thisdata may be used to calculate the frequency.

Referring to FIG. 21, a mobile device 62, such as a smartphone, mayinclude an app providing an INPUT if the Smart features are notintegrated into the OPEP device. The app may allow selection of thedesired feedback and adjustment of targets and/or limits.

Input on the user's quality of life is used to calculate a QoL scorewhich may be correlated with DFP performance. Various inputs may be usedto calculate a QoL score and algorithms could be tailored or adjustedfor different disease types. User input may be performed with anauxiliary input component, such as computer device, for example asmartphone app. Some examples of QoL inputs are:

St. George's Respiratory questionnaire for COPD

Simplified questionnaire

User's journal

Steps/day

Number of hours the user is sedentary

Various features and/or inputs for a device “wake up” include but arenot limited to one or more of an accelerometer, pressure sensor, flowsensor, humidity sensor, temperature sensor, mechanical switch/button,pressure switch, flow switch, temperature switch, infrared light sensor,conductive switch/lips on mouthpiece or hand on device/closing circuit,humidity sensor, flex sensor on membrane, capacitive displacement,linear variable differential transformer, conductive membrane,microphone, MAF sensor, hot wire, programmable timer/user/alarmreminder. Various features and/or inputs for a session identification(ID), session “start” and “stop” times and “duration” include a softwareclock and/or algorithm. Various features and/or inputs for the “breathcount” include but are not limited to an accelerometer, pressure sensor,flow sensor, humidity sensor, temperature sensor, microphone and/ormechanical switch. Inputs and features for the average pressure andaverage frequency include but are not limited to one or more of thevarious sensors discloses herein throughout. An “instant pressure alert”may include an algorithm that alerts the user in real time when apredetermined (preset) maximum pressure threshold is exceeded. The alertmay be visual (LED, screen display), haptic or audible. On or more of amucus number (lung obstruction level), cough number, and/or wheezingnumber may be calculated by algorithms from humidity, temperature, andmicrophone sensor data, including for example providing ratings for eachon a 1 to 10 scale. A breath temperature may be calculated by atemperature sensor, while breath humidity may be calculated by ahumidity sensor. A device alarm timer may be a programmable feature thatalerts/reminds the user to use the device. The snooze button may beactuated to reset/snooze the alarm for a predetermined time period(e.g., 10 minutes) up to a maximum number of resets (e.g., 6), with thereminder then being turned off automatically. A session pause/playfeature provides the user with the flexibility to pause the treatmentsession, for example if something important interrupts the session, andthen restart the session once it is more convenient. An algorithmcalculates actual use time, eliminating the pause time. A cleaningreminder may be visual (blinking LED lights), audible, or haptic. Thetimed reminder, based for example on the actual time used, number ofuses, number of breaths and/or total time, or some combination thereof,provide indicia or a reminder to clean the device as recommended. Thereminder may be programmed to provide an alert to fit a particularschedule. A device replacement warning provides the user and/or otherrecipient with indicia or a prompt that the device needs to be replaced.The reminder may be visual (blinking LED lights), audible, or haptic.The a warning may be based for example on the actual time used, numberof uses, number of breaths and/or total time, or some combinationthereof.

The warning may be programmed to provide an alert to fit a particularschedule. A therapy completion notification may be based on an algorithmthat calculates the time of a session based on the amount of breathes,and the session quality (e.g., average pressure within a recommendedrange (e.g., 10 to 20 cm/H₂O)). The data may be transmitted to connecteddevices (whether hardwired or wireless), including USB,

Bluetooth, WiFi and other known communication systems.

Outputs

Referring to FIGS. 22 and 23, an output is defined as new informationthat is leaving the Smart OPEP ‘system’, with the information beingcommunicated by an output component. The output may take the form ofvisual, audible, and sensory feedback, or be related to the user'squality of life and disease progress. A number of outputs and outputcomponents are suitable, including a visual output component, which maybe easily integrated into the Smart OPEP device and allow several levelsof feedback. For example, an array 150 of three (3) LEDs 152, each witha different color may indicate if the input is low, high, or acceptable.Instead of three (3) separate LEDs (e.g., red, amber and green), asingle tri-color LED 154 may also be used. If more than three (3)discreet states of feedback are required, then a LED bar graph 156 maybe used.

Referring to FIGS. 51, 55 and 59, the user interface may also include adisplay screen 420 (e.g., LED display screen), which may display variousdata and information, both in real time and on a command/retrieval base.The user interface/control module 408 may also include a micro USB port422 which provides for the transfer of data and/or charging of themodule. The module 408 may also include a micro SD card port 424, inwhich an SD card may be inserted to exchange (upload/download) data. Themodule may also include a microphone and/or speaker 426, which mayprovide the audible output, but also provide for audible input andcommands that may be recognized and followed operated/acted on by thecontrol module 408. The user interface may include a touch screen forinputting data and instructions to the control module.

Audible and sensory/tactile (vibration) outputs and output componentsmay also be used to provide feedback to the user. For example, sound orvibration occurs while the input is within the acceptable range, or ifthe input exceeds a specified limit.

A mobile device 62, or other computer interface, may function as theoutput component and provide an interface with a smartphone app as anoutput if the Smart features are not integrated into the OPEP device.The app could display real-time performance characteristics, datatrends, or games that motivate the user to complete a session.

Referring to FIGS. 62-76B and 83-87, the operation of the smart OPEPprovides a smart data logger. It should be understood that the userinterface and control module may be used with other types of respiratorycare systems. The user interface provides the patient/user, caregiver(e.g., doctor), insurers, and other health care providers with varioususeful information that may be used to further improve the health of thepatient/user. The interface may provide the various recipients withinformation and guidance on when to use the device, alerts if a pre-set(input) pressure threshold is exceeded, provide information about whenthe device should be cleaned (e.g., regular intervals) with minimalinput from the user, and inform the user and/or other intendedrecipients when the therapy session is completed. In one embodiment, theuser may pick up the device, use the device with minimalinteraction/effort (e.g., no manual logging or interfacing with anelectronic input device), and put the device back down until the nextuse. The module may record all of the information gathered by thevarious sensors and other inputs and live display it to the user, forexample through the display 420, or log/store the data for later review,for example by downloading it to an SD card inserted into the port 424,or to a computer or other device by way of the USB port 422. The devicemay also transmit the data wirelessly to a device, such as a PC, table,smart phone (e.g., mobile app), and other know and suitable devices. Asmentioned, the module may have a live display 420, or a connection(hardwire or wireless) to a smart device with a digital display, whereeither the module (via display 420 or microphone 426) or digital displaywould be able to alert the user, or other intended recipient, when it istime to perform a treatment session, inform the user when it is time toclean the device, inform the user when it is time to replace the device,and/or inform the user when the treatment session has been completed.The device may also inform the user, or intended recipient, aboutsession duration, number of breathes taken, average treatment pressure,average treatment frequency, maximum pressure warning, low batterywarning, mucus obstruction level, cough intensity level, wheezingintensity level, breath temperature and breath humidity level. Thedevice communication with the user may be visual, auditory or haptic.The user may also actuate a push button, or actuator 430, to delay orreset a reminder alarm (e.g., snooze) if not convenient at the moment.The actuator may also be actuated to power up (wake up) or turn on themodule.

In the embodiment of FIGS. 79-87, the accelerometer 930 senses movementand wakes the device up, for example movement in the 0 to 1 G range.Conversely, if the device is left undisturbed, the device will time outand go to sleep automatically.

In operation, and referring to FIGS. 63-76B and 85-85B, the module mayprovide a session reminder, e.g., auditory or visual alarm. The time andfrequency of the reminders may be programmable by the user and/or otherprovider, locally or remotely. Once the alarm is activated, the user mayreset the alarm with a delay (i.e., snooze), e.g., 10-30 minutes byactuating the actuator 430, or turn the time off altogether, for exampleby holding the button down or entering a sequence of button pushes. Ifthe snooze is not activated, the module will then determine whether aninput was received from one or more sensors, including a pressure, flow,humidity, temperature, flex sensor or membrane, capacitive displacement,linear variable differential transformer conductive membrane and/orlight curtain. For example, input about whether the user is blowing intothe device is detected. If an input, movement and/or action wasdetected, the device powers up, with the LED activated and the time/dateof the session being logged. If no input or action is detected, thedevice will again enter sleep mode.

Once the device is powered up, for example by turning on the switch 430,or by way of movement being detected by the accelerometer 930, with theLED indicating as much (see FIGS. 67 and 85A and B), an algorithmcalculates and records the average pressure of the session using inputfrom one more sensors, including for example and without limitation apressure, flex sensor on membrane, capacitive displacement, linearvariable differential transformer, conductive membrane and/or lightcurtain, or combinations thereof. The frequency of the sessions (e.g.,average thereof) may also be recorded based on input from one or moresensors, including a pressure, accelerometer, flex sensor on membrane,microphone, capacitive displacement, linear variable differentialtransformer, conductive membrane and/or light curtain, or combinationsthereof. The number of breaths during each session may also be recordedbased on input from one or more sensors, including a pressure, flow,humidity, temperature, flex sensor on membrane, microphone, capacitivedisplacement, linear variable differential transformer, conductivemembrane and/or light curtain, or combinations thereof. As the usercontinues to interface with the device, e.g., blow into the device, thesensors and module continue to record and calculate the data. Once thesensors and module determine the user is no longer using the device,e.g., blowing into the device, the device may time out after apredetermined time period (e.g., 10 sec. to 5 minutes), or the switchmay be turned off, with the LED providing an indicator that the deviceis no longer being powered.

The data may be stored in an SD card, and/or transmitted to a mobileapp, personal computer, whether hardwired or wirelessly.

During use, the visual display may display, or provide indicia about,the session date, start time, session duration timer, a sessionpause/play interface (e.g., touchscreen actuator), breath counter(number of exhalations), average exhalation duration, average pressure,average frequency, instant pressure alert (e.g., maximum exceeded) mucusnumber/rating, cough number/rating, wheezing number/rating, breathtemperature, breath humidity, average exhalation time (%) where thepressure >5 cmH₂O, device cleaning reminder or device life status. Thesame data/information may be stored, along with the sessionidentification and start time. The LED display may turn off after thesession is terminated and the device enters sleep mode.

Referring to FIG. 65, the actuator may be actuated, e.g., button pushed,to wake the device up, or an accelerometer may wake the device, whichactivates a visual display, e.g., LED light. As the user blows into thedevice, e.g. mouthpiece, the algorithm again calculates the number ofbreaths per session, the average pressure during the session and theinstant pressure (e.g. maximum) (manometer) using a pressure sensor 434or microthermal flow sensor 436. The LED array may provide a real timevisual display, or feedback, to the user about the instant pressure, forexample red (too high or exceeding maximum limit), amber(reaching/approaching maximum limit) or green (in predeterminedacceptable range).

The pressure sensor 434, 730 or microthermal flow sensor 436 may beseparated by a flexible membrane 440, 660 from the OPEP flow channel,with the membrane defining a sealed off chamber 438, 684 as shown inFIGS. 60-76B. The indirect pulsating pressure created by the membrane440, 660 in the chamber 438, 684 in response to the pulsating pressurein the OPEP is detected by the pressure sensor 434, 730. Likewise, theindirect pulsating air flow created by the membrane 440 response to thepulsating pressure in the OPEP is detected by the microthermal flowsensor. For example, the pulsating pressure in the OPEP may be 0 to 60cm H₂O.

Feature: Performance Targets

This feature provides feedback to the user based on specific performancetargets. For example, if the mean pressure is to be within 10 to 15cmH2O, this feature would notify the user that their mean pressure istoo high, too low, or acceptable. The performance targets can be set bythe patient or health care provider, or default to limits based ongenerally accepted treatment protocols.

The general layout for this feature is shown below in FIG. 24 andincludes a sensor 154, which may include without limitation any one ofthe sensors previously disclosed herein, or combinations thereof, theability to process raw data, including for example a processor 158, anoutput component 150, 154, 156 to display feedback, and if necessary,the ability to enter performance limits manually. The location of thesensor may change depending on the type of sensor selected or theperformance characteristic being measured as disclosed herein withrespect to various embodiments.

The performance characteristics that could be included in this featureare referred to above and herein. The following table lists exemplaryperformance characteristics and various suitable sensors for measuringthe characteristics.

TABLE 1 Performance Characteristics Fre- True Performance quen- MeanMean Upper Lower Characteristic cy Pressure Pressure Amplitude PressurePressure Pressure X X X X X X Sensor Flex Sensor X X X X X X Non-contactX X X X X X Position Sensor LVDT X X X X X X Conductive X X X X X XMembrane Hall Effect X X X X X X Sensor Light Curtain X X X X X X FlowSensor X Potentiometer X Vane Piezo Flex X Sensor LED/Photo X SensorProximity X Sensor Accelerometer X Microphone X

The flow chart for this feature is shown in FIG. 25. The dashed arearepresents an integrated embodiment that does not allow the targetlimits to be adjusted and in this case provides feedback on the meanpressure.

In operation, the user first selects the type of feedback. The “Get Type& Set Type” define the performance characteristic to be analyzed. Next,the user decides if custom targets are to be used and enters the limits.If not, default limits are set based on the performance characteristicselected. Next, the sensor 154 begins sending raw data and the selectedperformance characteristic is calculated. Next, a series of decisionsare made based on the calculated value of the performancecharacteristic. If the value is greater than the upper limit, then theoutput is high. If the value is less than the lower limit, then theoutput is low. If the value is neither, than the output is OK. Next, theflow chart checks if the user has selected to end the feedback. If not,then the cycle repeats. The above logic provides 3 discreet states offeedback. If required, additional logic could be added to provide afiner resolution to the feedback.

The analysis may either be completed using a processor 158, e.g., amicrocontroller, embedded in the PCB, or may be performed using anexternal computing device, such as mobile device, including a smartphoneor tablet. As seen in Table 1, frequency may be determined from anysensor, however, pressure outputs require a pressure sensor (eitherdirect or indirect). In order to calculate frequency from a pressureinput, processing techniques such as: Peak-to-Peak time, Fourieranalysis, or Auto-correlation may be used. FIG. 1 illustrates an exampleof a pressure waveform that has been processed using a Peak-to-Peaktechnique.

If the input is a sound signal it can be averaged to simplify thewaveform. The simpler waveform may then be processed in the same way asa pressure signal to determine frequency. Referring to FIG. 26, the rawsound data (bars) has been averaged using the Root Sum of Squarestechnique and the result is shown by the line. Each peak (dot) is thenidentified and the time between peaks is calculated and used todetermine the frequency.

The output for this feature can be visual 160, audible 162, or sensory164, and can be integrated into the device. An example of an integratedsolution is shown in FIGS. 4, and 27-29. In one embodiment, anintegrated solution would not provide for the selection of theperformance characteristics or adjustment of the performance limits. Inother embodiments, the integrated solution may provide a user interfacepermitting such selection and adjustment, for example through a keypad,buttons or touchscreen.

Referring to FIG. 31, the algorithm for calculating the performancecharacteristics including recording the raw data, filtering or smoothingthe raw data to remove any noise, which may be accomplished by knowntechniques including a moving average, Butterworth filter, Fourierfilter or Kernel filter. The direction of the slope is determined usingthe filtered/smoothed data, whether positive or negative, withincreasing=+1 and decreasing=−1. Slope changes between positive andnegative are identified and labelled as a peak, with changes fromnegative to positive labeled as a trough. For each peak and trough, thetimestamp and pressure value is logged. Exemplary data is shown in FIGS.46A and B. Using the time and pressure value for each peak and trough,the frequency, amplitude and mean pressures are calculated.

A frequency analysis may be performed using the time and pressure datashown in FIGS. 46A and B. The waveforms produced by the patterns, shownfor example in FIG. 46A, were analyzed by applying a moving average toremove noise and determine the peaks. The time (t) between peaks iscalculated, which outputs the frequencies (f), with f=f_(sample/t),where f_(sample)=1000 Hz.

The computing device, such as a mobile device including a smartphone 62,may function as the output device (and also the manual input (auxiliaryinput component) and analysis source). In these examples, the Smart OPEPcommunicates with the smartphone via a wireless protocol such asBluetooth as shown in FIG. 30. An application (app) will allow the userto input the desired performance characteristic and set the limits ifnecessary (FIG. 21). An output screen 170 will display the target limitsand provide feedback to the user (e.g., too high, too low, or ok) asshown in FIGS. 21, 23 and 32.

Referring to FIGS. 33 and 34, another possible output for this featuremay be to turn the session into a game. For example, and referring toFIG. 33, the bird 180 represents the current performance characteristicvalue, which must pass through the pipes 182 without going outside thelimits (upper and lower) 184, 186. If both frequency and pressuretargets are required, care must be taken to ensure that the user is notoverwhelmed with the feedback and is able to compensate their breathingtechnique to meet the required targets. A custom output graphic could bedeveloped to aid the user in controlling two performancecharacteristics, such as frequency and pressure. FIG. 34 illustrates anexample of a simple game that helps aid the user in controlling bothfrequency and pressure. The goal of the game is to get the ball into thehole and the current location of the ball is dependent on the frequencyand pressure.

Referring to FIGS. 45, 86 and 87, to start a therapy session, the userfirst wakes the OPEP device, for example by pushing a manual button orautomatically as the device is picked up by using the accelerometer 930.Once awake, the device pairs with a mobile device, such as a smartphone, if available. If a mobile device is available, an application maybe opened and any previous data saved in memory may be downloaded in themobile device. The user may be prompted to modify performance targets ifdesired. Once performance targets are set, the application opens thefeedback screen so that the user may monitor their performancethroughout the treatment. If a smart phone is not available, theprevious performance targets are used, and the data is saved internally.The OPEP device begins monitoring for positive pressure. If at any pointduring treatment, the device does not detect a positive pressure changefor a specified amount of time, the device saves any treatment data toeither the mobile device or the internal memory and enters a standbymode to conserve power. If positive pressure is detected, the OPEPdevice will begin to measure the pressure (positive and negative),calculate the performance characteristics such as frequency, amplitudeand mean pressures and provide feedback to the user regarding theirtechnique.

One aspect of the embodiments disclosed herein relates to the handlingof data. Data logged by the OPEP may be transferred to an externaldevice, such as a smartphone, tablet, personal computer, etc. If such anexternal device is unavailable, the data may be stored internally in theOPEP in a data storage module or other memory and transferred upon thenext syncing between the OPEP and external device. Software mayaccompany the OPEP to implement the data transfer and analysis.

In order to provide faster and more accurate processing of the data, forexample from one or more various sensors, generated within the smartOPEP, data may be wirelessly communicated to a smart phone, localcomputing device and/or remote computing device to interpret and act onthe raw sensor data.

In one implementation, the smart OPEP includes circuitry fortransmitting raw sensor data in real-time to a local device, such as asmart phone. The smart phone may display graphics or instructions to theuser and implement processing software to interpret and act on the rawdata. The smart phone may include software that filters and processesthe raw sensor data and outputs the relevant status informationcontained in the raw sensor data to a display on the smart phone. Thesmart phone or other local computing device may alternatively use itslocal resources to contact a remote database or server to retrieveprocessing instructions or to forward the raw sensor data for remoteprocessing and interpretation, and to receive the processed andinterpreted sensor data back from the remote server for display to theuser or a caregiver that is with the user of the smart OPEP.

In addition to simply presenting data, statistics or instructions on adisplay of the smart phone or other local computer in proximity of thesmart OPEP, proactive operations relating to the smart OPEP may beactively managed and controlled. For example, if the smart phone orother local computer in proximity to the smart OPEP determines that thesensor data indicates the end of treatment has been reached, or thatfurther treatment is needed, the smart phone or other local computingdevice may communicate such information directly to the patient. Othervariations are also contemplated, for example where a remote server incommunication with the smart phone, or in direct communication with thesmart OPEP via a communication network, can supply the information andinstructions to the patient/user.

In yet other implementations, real-time data gathered in the smart OPEPand relayed via to the smart phone to the remote server may trigger theremote server to track down and notify a physician or supervisingcaregiver regarding a problem with the particular treatment session or apattern that has developed over time based on past treatment sessionsfor the particular user. Based on data from the one or more sensors inthe smart OPEP, the remote server may generate alerts to send via text,email or other electronic communication medium to the user, the user'sphysician or other caregiver.

The electronic circuitry in the smart OPEP (e.g. the controllerarrangement of FIGS. 4, 44, 83 and 84), the local computing deviceand/or the remote server discussed above, may include some or all of thecapabilities of a computer in communication with a network and/ordirectly with other computers. As illustrated in FIGS. 49 and 50, thecomputer 500 may include a processor 502, a storage device 516, adisplay or other output device 510, an input device 512, and a networkinterface device 520, all connected via a bus 508. A battery 503 iscoupled to and powers the computer. The computer may communicate withthe network. The processor 502 represents a central processing unit ofany type of architecture, such as a CISC (Complex Instruction SetComputing), RISC (Reduced Instruction Set Computing), VLIW (Very LongInstruction Word), or a hybrid architecture, although any appropriateprocessor may be used. The processor 502 executes instructions andincludes that portion of the computer 500 that controls the operation ofthe entire computer. Although not depicted in FIGS. 49 and 50, theprocessor 502 typically includes a control unit that organizes data andprogram storage in memory and transfers data and other informationbetween the various parts of the computer 500. The processor 502receives input data from the input device 512 and the network 526 readsand stores instructions (for example processor executable code) 524 anddata in the main memory 504, such as random access memory (RAM), staticmemory 506, such as read only memory (ROM), and the storage device 516.The processor 502 may present data to a user via the output device 510.

Although the computer 500 is shown to contain only a single processor502 and a single bus 508, the disclosed embodiment applies equally tocomputers that may have multiple processors and to computers that mayhave multiple busses with some or all performing different functions indifferent ways.

The storage device 516 represents one or more mechanisms for storingdata. For example, the storage device 516 may include a computerreadable medium 522 such as read-only memory (ROM), RAM, non-volatilestorage media, optical storage media, flash memory devices, and/or othermachine-readable media. In other embodiments, any appropriate type ofstorage device may be used. Although only one storage device 516 isshown, multiple storage devices and multiple types of storage devicesmay be present. Further, although the computer 500 is drawn to containthe storage device 516, it may be distributed across other computers,for example on a server.

The storage device 516 may include a controller (not shown) and acomputer readable medium 522 having instructions 524 capable of beingexecuted on the processor 502 to carry out the functions described abovewith reference to processing sensor data, displaying the sensor data orinstructions based on the sensor data, controlling aspects of the smartOPEP to alter its operation, or contacting third parties or otherremotely located resources to provide update information to, or retrievedata from those remotely located resources. In another embodiment, someor all of the functions are carried out via hardware in lieu of aprocessor-based system. In one embodiment, the controller is a webbrowser, but in other embodiments the controller may be a databasesystem, a file system, an electronic mail system, a media manager, animage manager, or may include any other functions capable of accessingdata items. The storage device 516 may also contain additional softwareand data (not shown), which is not necessary to understand theinvention.

The output device 510 is that part of the computer 500 that displaysoutput to the user. The output device 510 may be a liquid crystaldisplay (LCD) well-known in the art of computer hardware. In otherembodiments, the output device 510 may be replaced with a gas orplasma-based flat-panel display or a traditional cathode-ray tube (CRT)display. In still other embodiments, any appropriate display device maybe used. Although only one output device 510 is shown, in otherembodiments any number of output devices of different types, or of thesame type, may be present. In one embodiment, the output device 510displays a user interface. The input device 512 may be a keyboard, mouseor other pointing device, trackball, touchpad, touch screen, keypad,microphone, voice recognition device, or any other appropriate mechanismfor the user to input data to the computer 500 and manipulate the userinterface previously discussed. Although only one input device 512 isshown, in another embodiment any number and type of input devices may bepresent.

The network interface device 520 provides connectivity from the computer500 to the network 526 through any suitable communications protocol. Thenetwork interface device 520 sends and receives data items from thenetwork 526 via a wireless or wired transceiver 514. The transceiver 514may be a cellular frequency, radio frequency (RF), infrared (IR) or anyof a number of known wireless or wired transmission systems capable ofcommunicating with a network 526 or other smart devices 102 having someor all of the features of the example computer of FIGS. 49 and 50. Thebus 508 may represent one or more busses, e.g., USB, PCI, ISA (IndustryStandard Architecture), X-Bus, EISA (Extended Industry StandardArchitecture), or any other appropriate bus and/or bridge (also called abus controller).

The computer 500 may be implemented using any suitable hardware and/orsoftware, such as a personal computer or other electronic computingdevice. The computer 500 may be a portable computer, laptop, tablet ornotebook computers, smart phones, PDAs, pocket computers, appliances,telephones, and mainframe computers are examples of other possibleconfigurations of the computer 500. The network 526 may be any suitablenetwork and may support any appropriate protocol suitable forcommunication to the computer 500. In an embodiment, the network 526 maysupport wireless communications. In another embodiment, the network 526may support hard-wired communications, such as a telephone line orcable. In another embodiment, the network 526 may support the EthernetIEEE (Institute of Electrical and Electronics Engineers) 802.3xspecification. In another embodiment, the network 526 may be theInternet and may support IP (Internet Protocol). In another embodiment,the network 526 may be a LAN or a WAN. In another embodiment, thenetwork 526 may be a hotspot service provider network. In anotherembodiment, the network 526 may be an intranet. In another embodiment,the network 526 may be a GPRS (General Packet Radio Service) network. Inanother embodiment, the network 526 may be any appropriate cellular datanetwork or cell-based radio network technology. In another embodiment,the network 526 may be an IEEE 802.11 wireless network. In still anotherembodiment, the network 526 may be any suitable network or combinationof networks. Although one network 526 is shown, in other embodiments anynumber of networks (of the same or different types) may be present.

It should be understood that the various techniques described herein maybe implemented in connection with hardware or software or, whereappropriate, with a combination of both. Thus, the methods and apparatusof the presently disclosed subject matter, or certain aspects orportions thereof, may take the form of program code (i.e., instructions)embodied in tangible media, such as floppy diskettes, CD-ROMs, harddrives, or any other machine-readable storage medium wherein, when theprogram code is loaded into and executed by a machine, such as acomputer, the machine becomes an apparatus for practicing the presentlydisclosed subject matter. In the case of program code execution onprogrammable computers, the computing device generally includes aprocessor, a storage medium readable by the processor (includingvolatile and non-volatile memory and/or storage elements), at least oneinput device, and at least one output device. One or more programs mayimplement or use the processes described in connection with thepresently disclosed subject matter, e.g., through the use of an API,reusable controls, or the like. Such programs may be implemented in ahigh level procedural or object-oriented programming language tocommunicate with a computer system. However, the program(s) can beimplemented in assembly or machine language, if desired. In any case,the language may be a compiled or interpreted language and it may becombined with hardware implementations. Although exemplary embodimentsmay refer to using aspects of the presently disclosed subject matter inthe context of one or more stand-alone computer systems, the subjectmatter is not so limited, but rather may be implemented in connectionwith any computing environment, such as a network or distributedcomputing environment. Still further, aspects of the presently disclosedsubject matter may be implemented in or across a plurality of processingchips or devices, and storage may similarly be spread across a pluralityof devices. Such devices might include personal computers, networkservers, and handheld devices, for example.

Providing feedback to users regarding their technique is one feature ofthe smart OPEP that will help optimize treatment. A controller 158,which may be located on or inside the various embodiments of the smartOPEP described herein, is in communication with one or more sensors,switches and or gauges that are tracking or controlling operation of thesmart OPEP. The controller may store data gathered in a memory for laterdownload to a receiving device, or may transmit data to a receivingdevice in real-time. Additionally, the controller may perform someprocessing of the gathered data from the sensors, or it may store andtransmit raw data. RF transmitter and/or receiver modules may beassociated with the controller on the smart OPEP to communicate withremote hand-held or fixed computing devices in real-time or at a latertime when the smart OPEP is in communication range of a communicationnetwork to the remote hand-held or fixed location computing devices. Thecontroller may include one or more of the features of the computersystem 500 shown in FIG. 49. Additionally, the one or more sensors,switches or gauges may be in wired or wireless communication with thecontroller.

For clarity in displaying other features of the various Smart OPEPembodiments described, the controller circuitry is omitted from someillustrations, however a controller or other processing agent capable ofat least managing the routing or storing of data from the smart OPEP iscontemplated in one version of these embodiments. In otherimplementations, the smart OPEP may not include an onboard processor andthe various sensors, gauges and switches of a particular embodiment maywirelessly communicate directly with a remotely located controller orother processing device, such as a handheld device or remote server. Oneembodiment of a circuit is shown in FIGS. 83-85B. Data gathered by acontroller or other processing device may be compared to expected orpre-programmed values in the local controller memory or other remotelocation to provide the basis for feedback on whether desiredperformance or therapy is taking place. If the controller is a moresophisticated and includes more of the computer 500 elements describedin FIG. 49, then this processing may all be local to the smart OPEP. Inmore rudimentary controller arrangements, the data may simply bedate/time stamped and stored locally or remotely for later processing.In one embodiment, the data may further be locally or remotely stampedwith a unique device or patient identifier.

Feature: Performance Limits

Referring to FIG. 35, the patient or HCP may be notified if a pressurecharacteristic is exceeded. The main purpose for this feature is toensure patient safety and is a simplified version of the previousfeature. For example, OPEP therapy is used post-operatively and patientsmay need to remain below a certain pressure. The flow chart in FIG. 35is similar to the flow chart of FIG. 25, but only contains an upperlimit. Any of the outputs discussed above may be used in this feature,such as visual, audible, vibration, or a smartphone display.

Feature: Real-Time DFP Feedback

Previous features may only inform the user if the input is high, low, oracceptable. An additional feature provides quantitative real-timefeedback of the desired performance characteristic.

All of the inputs listed in the previous features can be used for thisfeature:

10.2.1. Pressure Sensor

10.2.2. Flex Sensor

10.2.3. Non-contact Position Sensor

10.2.4. LVDT

10.2.5. Conductive Membrane

10.2.6. Hall Effect Sensor

10.2.7. Light Curtain

10.2.8. Flow Sensor

10.2.9. Potentiometer Vane

10.2.10. Piezo Flex Sensor

10.2.11. LED/Photo Sensor

10.2.12. Proximity Sensor

10.2.13. Accelerometer

10.2.14. Microphone

The inputs can be analyzed to determine:

10.3.1. Peak and valley detection

10.3.2. Average peak

10.3.3. Average valley

10.3.4. Amplitude

10.3.5. Mean pressure

10.3.6. True mean pressure

10.3.7. Frequency

In order to display the DFP in real-time, a computer device, such as alaptop, smartphone, or tablet, or other separate device with a displayis required.

Feature: DFP History

Another feature provides a way for the patient or HCP to review DFP datafrom previous sessions. DFP data can be displayed over time and the usercan retrieve and display the data by some temporal component, includingfor example and without limitation day, week, month, year, or all time.This allows the user to quickly visualize trends in the performance.

Feature: Ensure Proper Setting

This feature provides feedback to the user regarding the appropriateresistance setting. In one embodiment, the OPEP device provides five (5)resistance settings which change the frequency, amplitude and meanpressure performance. For a given flow rate, increasing the resistancesetting increases the frequency and pressure characteristics. In oneembodiment, for example the Aerobika® OPEP device IFU, the correctresistance setting will produce an I:E ratio of 1:3 or 1:4 for 10-20 minwithout excess fatigue. Therefore, the input will be used to identifythe start and end of the inspiratory and expiratory cycles. Somepossible inputs include a flow sensor, pressure sensor, or microphone.

A flow sensor may be placed in the mouthpiece and used to determine theI:E ratio. A single flow sensor, placed at location 1 in FIG. 36, wouldneed to be able to measure flow in both directions. It would also bepossible to use two (2) one-way flow sensors: one in the location 1 forexhalation and one in location 2, as shown in FIG. 36, for inhalation.

A pressure sensor may be used to calculate the I:E ratio. If thepressure is negative then the flow is inspiratory, and if the pressureis positive then the flow is expiratory. The pressure sensor may bepositioned as shown in FIG. 24.

In an alternative embodiment, two (2) microphones may to be used for thecalculation of the I:E ratio, similar to the dual flow sensors shown inFIG. 36. A single microphone would only be able to identify if flow isoccurring, and not if it is inspiratory or expiratory.

To analyze the I:E ratio, four (4) time points need to be determined:the start and end of inhalation (T1 and T2), and the start and end ofexhalation (T3 and T4). The analysis could follow the logic shown inFIG. 37. If two (2) sensors are used, additional logic is required todetermine if the flow is inspiratory or expiratory.

-   -   If Sensor 1 is ON and Sensor 2 is OFF        -   Then flow is expiratory    -   If Sensor 1 is ON and Sensor 2 is ON        -   Then flow is inspiratory

The output of this feature would make recommendations to the user toeither increase resistance, decrease resistance, or leave the resistancesetting unchanged. An output component may be embedded in the device andbe either visual, audible, or tactile as shown in FIGS. 27-28, or, theoutput may be shown on a separate device such as a smartphone, or othercomputer device or screen.

Feature: Setting Recommendation Based on Previous Data

This feature will analyze previous DFP data and make settingrecommendations. This feature may calculate the I:E Ratio for eachbreath and then calculate the average I:E Ratio for a session. Based onthe average I:E Ratio, this feature would make a setting changerecommendation using the logic shown in FIG. 37 and/or referred toabove.

Feature: Proper Technique

This feature will provide the user with training and coaching on propertechnique for performing an OPEP maneuver based on the IFU, and may beupdated for other devices. In one embodiment, this feature may take theform of an app, and will communicate with the OPEP device via BTLE (seeFIG. 4 for more details).

A proper OPEP maneuver relies on several variables, such as I:E Ratio,frequency, pressure, and setting. These inputs have been previouslydiscussed.

The ideal OPEP maneuver follows these steps: Inhale slowly, taking adeeper breath than normal but not filling the lungs, hold your breathand exhale actively. To analyze the first step, the app needs to learnthe user's breathing pattern. This is done during the initial setup ortraining session and could be re-evaluated if the user's performancechanges. To start, the user would inhale normally through the device inorder to calculate their baseline inspiratory pressure, or IP_(Tidal),or Tidal Volume (TV). Next, the user would inhale fully through thedevice to calculate their maximum inspiratory pressure, or IP_(max), orInspiratory Capacity (IC). The app would then calculate the targetinspiratory pressure (IP_(target)) or volume for step #1 which is morethan IP_(tidal) (or the Tidal Volume) and less than the IP_(max) (orInspiratory Capacity). A starting point for the IP_(target) (or targetinspiratory volume) would be the average of IP_(tidal) and IP_(max) (orthe TV and the IC).

The next step involves holding your breath for 2-3 seconds. Breathhold=T3−T2.

Next, the user exhales actively, but not forcefully. Frequency andpressures should be within target range and exhalation should last 3-4times longer than inhalation. Exhaling actively is a subjectivedescription of the OPEP maneuver, therefore, the app will calculate thefrequency, mean pressure and I:E ratio in real-time, and use thatinformation and data to determine if the proper technique is beingachieved.

The output of this coaching feature will guide the user toward thecorrect OPEP technique based on the user's breathing pattern andspecific performance targets. If any of steps above are not performedcorrectly, the app will make suggestions to change the user's technique.For example, if the user doesn't hold their breath before exhaling, theapp would offer a reminder. In another example, the app may suggest thatthe user increase their flow rate because the mean pressure is too lowand is not within the accepted limits. To declare the user “trained”,the app may require the user to demonstrate a proper OPEP maneuverseveral times. The app could also play audio of a proper OPEP maneuver,which may assist the user in exhaling actively. The app may also includetraining videos explaining the proper technique and examples of peopleperforming proper OPEP maneuvers. The app may also notify the user'shealthcare provider (HCP) if proper technique isn't being completed.

Feature: Session Assist

In addition to the coaching feature, the Smart OPEP device can assistthe user in following the correct therapy regime. Session Assistfeatures aid the user or HCP in completing an OPEP session. For thefirst time user, an OPEP session can be confusing and complicated. Theuser needs to count the number of breaths, remember proper technique,remember when to perform ‘Huff’ coughs, and etc. For example, theAerobika® OPEP device IFU recommends the following steps: perform 10-20OPEP maneuvers or breaths, after at least 10 breaths, perform 2-3 ‘Huff’coughs, repeat for 10-20 minutes twice/day on a regular base, increaseto 3-4 times/day if needed.

Using the inputs defined earlier, this feature would count the number ofbreaths and provide feedback to the user, either with the numberremaining or the number completed. The app would then remind the user toperform ‘Huff’ coughs after the appropriate number of breaths, and thenrepeat the breath counting/huff cough cycle for 10-20 minutes. The usermay input the total number of breaths to complete or total session timeas a goal and track progress. The Session Assist feature would alsotrack the number of sessions per day, which can be used to determine theuser's progress or quality of life.

Feature: Quality of Life Score

This feature transforms quantitative data into qualitative data that iseasier for the user, HCP, or payer to understand. There are three (3)steps involved: determine the user's Quality of Life (QoL) score,correlate past DFP performance to QoL score, and predict QoL score basedon DFP performance trends. Various inputs may be used to calculate a QoLscore which will be correlated with DFP performance. Inputs may be bothqualitative and quantitative. Algorithms may be tailored or adjusted fordifferent disease types. Some examples of QoL inputs are: St. George'sRespiratory questionnaire for COPD, simplified questionnaire, user'sjournal, steps/day, and/or number of hours the user is sedentary.

The objective is to calculate a QoL score that evolves over time as theuser's condition improves or worsens. Initially, the user completes aquestionnaire and a baseline QoL score is computed. The user's journalwould be scanned for keywords such as: good day, bad day, cough, out ofbreath, etc., and the QoL score would be adjusted based on the number oftimes keywords appear (i.e. good day=+1, out of breath=−1). Theapplication may also calculate (or integrate with another app or devicesuch as a FitBit) the number of steps taken per day and use thisinformation to adjust the QoL score.

Once a QoL score has been generated, the app would determine arelationship between the QoL score and the measurements in the DFPhistory. This would require a period of time when the app is ‘learning’how the two (2) variables relate. In the following example, after oneweek of OPEP sessions (2×/day) and daily QoL input from the user, thefollowing linear regression equation is defined: QoL=5.6×MP−6.8 as shownin FIG. 39. A linear regression equation may also be calculated for eachof the other measurable and the equations with the highest “m” magnitude(y=mx+b) would be used to predict the QoL score. For example, if theFrequency/Qol equation was: QoL=1.2F+5.2 it would indicate that, forthis particular user, changes in frequency would be less likely toindicate a change in QoL than changes in Mean Pressure. A flow chart forthis feature is shown in FIG. 40. Outputs for this feature include:current and previous QoL score, suggestions improve QoL score,measureable vs. QoL score and linear regression results, encouragementwhen QoL score decrease, and/or notification to HCP when QoL scoredecreases.

Feature: Device Status

This feature provides feedback to the user about the device itself.Several options exist, including notifying the user, HCP or payer thatthe device needs to be replaced. This may take the form of a reminder inthe app, or could lockout features until a new lot number or serialnumber is entered. The feedback may also include notifying the user whenthe device needs to be cleaned. Cleaning notifications could be based onthe number of sessions between cleaning and/or changes in deviceperformance over time.

Feature: Stakeholder Updates

A stakeholder is defined as an individual or organization, outside thepatient's immediate family, that has an interest in the patient'scondition, treatment, and progress. Stakeholders may be the patient'sdoctor, respiratory therapists, hospital, or insurance company. Someexamples of stakeholder updates include: updating an insurance companywith the user's usage data to monitor patient adherence and/or updatingHCP with user's progress since last visit, usage data, and QoL score.

Feature: Active OPEP

Referring to FIG. 41, a device is disclosed that automatically adjuststhe resistance to keep the selected performance characteristic (e.g.,pressure (amplitude) and/or frequency) in the desired range. The rangeand/or performance characteristic to be controlled may be pre-programmedinto the device or be inputted by the user as described above. Themicroprocessor would receive data from the sensor and an algorithm woulddecide how to adjust the device. The microprocessor would then give acommand to a motor 190 and the motor would physically perform theadjustment of a control component, such as the valve seat 148 ororientation of the chamber inlet. The encoder 192 would confirm theposition of the motor and provide that information back to themicroprocessor. This would improve user adherence since all the userneeds to do is exhale into the device. The device will automatically setand control the resistance setting to achieve the desired therapy.Another option would be to program into the algorithm variations infrequency or pressure as some research has shown to be beneficial.

Feature: Lung Health

Referring to FIG. 42, one embodiment includes a flow sensor, which makesit possible to evaluate the patient's lung health by turning off theoscillations and allowing the device to operate like a spirometer. Theflow sensor would need to be able to measure flow in both directions(inspiratory and expiratory). An algorithm take the flow being measuredand generate a flow-volume loop shown below in FIG. 42. From the FVLoop, various parameters may be calculated and fed back to the patient.

Although the present invention has been described with reference topreferred embodiments, those skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. As such, it is intended that the foregoingdetailed description be regarded as illustrative rather than limitingand that it is the appended claims, including all equivalents thereof,which are intended to define the scope of the invention.

1. An oscillating positive expiratory pressure system comprising: anoscillating positive expiratory pressure device; an adapter removablycoupled to the oscillating positive expiratory pressure device, theadapter comprising a flow channel; and a control module coupled to theadapter and in communication with the flow channel, the control modulecomprising a visual display.
 2. The oscillating positive expiratorypressure system of claim 1 wherein the adapter is removably coupledbetween a mouthpiece and the oscillating positive expiratory pressuredevice.
 3. The oscillating positive pressure system of claim 2 whereinthe adapter comprises a first end coupled to the oscillating positiveexpiratory pressure device, a second end opposite the first end coupledto the mouthpiece, wherein the flow channel is defined between the firstand second ends, and a port communicating with the flow channel betweenthe first and second ends.
 4. The oscillating positive expiratorypressure system of claim 3 further comprising a pressure sensor and/ormicrothermal flow sensor and a flexible membrane disposed across theport and defining a chamber adjacent the pressure sensor and/ormicrothermal flow sensor.
 5. The oscillating positive expiratorypressure system of claim 4 wherein the membrane is coupled to theadapter with a tether.
 6. The oscillating positive expiratory pressuresystem of claim 3 wherein control module is releasably coupled to theadapter.
 7. The oscillating positive expiratory pressure system of claim4 wherein the membrane has a first side in fluid communication with theflow channel and a second, opposite side, wherein the chamber comprisesa first chamber defined on the second side of the membrane, and furthercomprising a second chamber defined on the first side of the membrane,and a damping orifice communicating between the flow channel and secondchamber.
 8. The oscillating positive expiratory pressure system of claim1 wherein the control module further comprises a data port, includingone or more of an SD or USB port, a microphone and an LED array. 9-18.(canceled)
 19. A smart accessory for an oscillating expiratory pressuredevice comprising: an adapter comprising a first end adapted to becoupled to the oscillating positive expiratory pressure device, a secondend opposite the first end, a flow channel defined between the first andsecond ends, and a port communicating with the flow channel between thefirst and second ends; a flexible membrane disposed across the port andcomprising a first side in flow communication with the flow channel andan opposite second side defining in part a chamber; a pressure sensorand/or microthermal flow sensor in flow communication with the chamber;and a control module coupled to the adapter and operative to collectdata from the pressure sensor and/or microthermal flow sensor.
 20. Thesmart accessory of claim 19 wherein the membrane is coupled to theadapter with a tether.
 21. The smart accessory of claim 19 whereincontrol module is releasably coupled to the adapter.
 22. The smartaccessory of claim 19 wherein the chamber comprises a first chamberdefined on the second side of the membrane, and further comprising asecond chamber defined on the first side of the membrane, and a dampingorifice communicating between the flow channel and second chamber. 23.The smart accessory of claim 19 wherein the control module furthercomprises a data port, including one or more of an SD or USB port, amicrophone and an LED array.
 24. The smart accessory of claim 19 whereinthe first end comprises a first tubular portion and the second endcomprises a second tubular portion.
 25. The smart accessory of claim 24further comprising a mouthpiece coupled to the second tubular portion.26-29. (canceled)
 30. The oscillating positive pressure expiratorypressure system of claim 3 wherein the adapter comprises a body definingthe flow channel and the port comprises a conduit extending from thebody, the conduit comprising an inlet in flow communication with theflow channel and an outlet in flow communication with the controlmodule.
 31. The oscillating positive pressure expiratory pressure systemof claim 30 wherein the flow channel defines a first axis and theconduit comprises a first portion extending from the inlet along asecond axis, wherein the first and second axes define an acute angle.32. The oscillating positive pressure expiratory pressure system ofclaim 31 wherein the conduit comprises a second portion extendingbetween the first portion and the outlet, wherein the second portiondefines a third axis, wherein the first and third axes are substantiallyparallel.
 33. The oscillating positive pressure expiratory pressuresystem of claim 30 further comprising a pressure stabilizer orifice incommunication with the conduit between the inlet and outlet.
 34. Theoscillating positive pressure expiratory pressure system of claim 33wherein the pressure stabilizer orifice has a first cross-sectionalarea, wherein the conduit defines a flow passageway having a minimumsecond cross-sectional area, and wherein the first cross-sectional areais less than the minimum second cross-sectional area.
 35. Theoscillating positive pressure expiratory pressure system of claim 33wherein the outlet comprises a first outlet, and wherein the conduitdefines a flow passageway and further comprises a second outletpositioned between the inlet and first outlet, wherein the second outletcommunicates with the flow passageway, and further comprising a plugdisposed in the second outlet across at least a portion of the flowpassageway, wherein the plug defines at least in part the pressurestabilizer orifice.
 36. The oscillating positive pressure expiratorypressure system of claim 35 wherein the plug comprises a cutout alignedwith the flow passageway to define the pressure stabilizer orifice, andwherein the plug is moveable such that a size of the pressure stabilizerorifice is adjustable.
 37. The oscillating positive pressure expiratorypressure system of claim 7 comprising a curved wall defining at least inpart the second chamber.
 38. A smart accessory for an oscillatingexpiratory pressure device comprising: an adapter comprising a bodyhaving a first end adapted to be coupled to the oscillating positiveexpiratory pressure device, a second end opposite the first end, a flowchannel defined between the first and second ends, and a conduitextending from the body, the conduit defining a flow passageway havingan inlet in flow communication with the flow channel between the firstand second ends and an outlet; and a control module coupled to theoutlet of the conduit and operative to collect pressure data from theflow passageway.
 39. The smart accessory of claim 30 further comprisinga pressure stabilizer orifice in communication with the flow passagewaybetween the inlet and outlet.
 40. The smart accessory of claim 39wherein the outlet comprises a first outlet, and wherein the flowpassageway comprises a second outlet positioned between the inlet andfirst outlet, wherein the second outlet communicates with the flowpassageway, and further comprising a plug disposed in the second outletacross at least a portion of the flow passageway, wherein the plugdefines at least in part the pressure stabilizer orifice.
 41. The smartaccessory of claim 35 wherein the size of the pressure stabilizerorifice is adjustable.
 42. An oscillating positive expiratory pressuresystem comprising: an oscillating positive expiratory pressure device;an adapter comprising: a body having a first end removably coupled tothe oscillating positive expiratory pressure device, a second endopposite the first end, a flow channel defined between the first andsecond ends, and a port communicating with the flow channel between thefirst and second ends; a flexible membrane disposed across the port andcomprising a first side in fluid communication with the flow channel anda second, opposite side; a first chamber defined on the second side ofthe membrane; a pressure sensor and/or microthermal flow sensor in flowcommunication with the first chamber; a second chamber defined on thefirst side of the membrane; and a damping orifice communicating betweenthe flow channel and second chamber; and a control module coupled to theadapter and operative to collect data from the pressure sensor and/ormicrothermal flow sensor.
 43. The oscillating positive pressureexpiratory pressure system of claim 42 wherein the body comprises acurved wall defining at least in part the second chamber, wherein thecurved wall has a concave side defining at least in part the secondchamber and a convex side defining at least in part the flow channel.